Aspirating/ventilating apparatus and method

ABSTRACT

A ventilating and aspirating assembly comprising an aspirating catheter tube internally disposed within and coextensive with a surrounding flexible collapsible sterility preserving film envelope, a connector by which ventilating air is involuntarily delivered to and exhausted from the lungs of a medical patient, said connector comprising structure which accommodates the manual insertion of the catheter tube into and manual removal from the trachea/bronchi patient through the connector. This facilitates aspiration of undesired respiratory fluids. The assembly further comprises a detachable connection site for one end of the envelope to the connector and a valve by which aspirating vacuum pressure is selectively communicated to the interior of the catheter tube for evacuation of said respiratory fluids, the valve comprising structure isolating the vacuum pressure from the atmosphere, structure by which the valve is placed in either of a locked and an unlocked condition and structure normally biasing and sealing the valve in a closed position, but accommodating manual displacement counter to the bias into an unsealed open position whereby, with the catheter tube indwelling in the lungs of the patient, the vacuum pressure causes evacuation of fluid from the patient&#39;s respiratory system through the catheter tube, and a detachable connection site for the other end of the envelope to the valve.

CONTINUITY

The application is a division of U.S. patent application Ser. No.633,570, filing July 23, 1984, now U.S. Pat. No. 4,569,344, issued Feb.11, 1986.

FIELD OF INVENTION

The present invention relates broadly to machine ventilation of therespiratory system of a medical patient and selected evacuation ofaccumulated fluids from within the trachea/bronchi of the patient, and,more particularly to a single novel apparatus (and related method) forconjointly so ventilating and selectively aspirating the respiratorysystem of the patient.

PRIOR ART

Alternate use and successive removal of endotracheal tubes and fluidaspiratory tubes to sequentially respirate and aspirate the trachea andbronchi of a medical patient has fallen into disrupt because of severalattending and well known disadvantages, not the least of which ispatient trauma and risk. In lieu thereof, it has been proposed that asingle coupling mechanism be connected to the patient for an essentiallylong term interval, which functions, selectively, to ventilate andaspirate. See U.S. Pat. No. 3,991,762.

However, such proposals have also suffered from serious drawbacks,including but not limited to being of relatively expensive andcumbersome components, capable of causing inadvertent aspiration,imposing torque upon the aspirating catheter tube, using potentiallyharmful mechanical manipulation of the catheter tube, capable of causingstress tearing of a sterile envelope around the catheter tube,presenting difficulty in assembling and disassembling and ventingsuction to the atmosphere during non-aspiration.

With the foregoing in mind, in brief summary, the present inventionovercomes or substantially alleviates the problems of the prior art,mentioned abbreviatedly above, and comprises an apparatus (and relatedmethod) which integrates into a single unit the selective capacity toboth involuntarily respirate a patient and aspirate fluids from apatient's trachea and bronchi. The apparatus, among other things,reduces trauma and risk, prevents inadvertent aspiration caused byeither the attending nurse or the patient, prevents interruption ofpositive ventilating pressure by the existence and manipulation of theaspirating catheter tube, comprises relatively inexpensive, facile andreliable components, imposes only axial forces upon a flexible envelope(which surrounds and preserves the sterility of the catheter tube) andupon the catheter tube as well, does not mechanically manipulate thecatheter tube, is easily assembled and disassembled (in whole or inpart--even when the apparatus is connected to the patient) and whichdoes not vent suction to the atmosphere when not aspirating.

Accordingly, it is a primary object of this invention to provide a novelventilating and aspirating apparatus and method which overcome orsubstantially alleviate the problems of the prior art.

Another important object is the provision of a novel apparatus (andmethod) which integrates into a single unit the selective capacity toboth involuntarily respirate a medical patient and aspirate fluids fromthe patient's trachea and bronchi.

Another significant object of the present invention is to provide anovel apparatus and method, of the type in question, which achieves oneor more of the following: reduces trauma and risks, prevents inadvertentaspiration caused by either the attending nurse or the patient, preventsinterruption of positive ventilating pressure by the existence andmanipulation of the aspirating catheter tube, comprises relativelyinexpensive, facile and reliable components, imposes only axial forcesupon a flexible envelope (which surrounds and preserves the sterility ofthe catheter tube) and upon the catheter tube a well, does notmechanically manipulate the catheter tube, is easily assembled anddisassembled (in whole or in part--even when the apparatus is connectedto the patient) and which does not vent suction to the atmosphere whennot aspirating.

A further dominant object is the provision of a ventilating/aspiratingmechanism which comprises a novel aspirating valve which may be lockedagainst inadvertent actuation.

Another paramount object of this invention is the provision of anaspirating valve which comprise a novel spring/sealing member.

An additional object of significance is the provision of a novelventilating/aspirating apparatus which is greatly simplified, highlyreliable, easy to use, cost effective, contamination free, preservessterility and is safe and effective in use.

These and other objects and features of the present invention will beapparent from the detailed description taken with reference to theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective, with parts shown schematically, of a presentlypreferred ventilator/aspirator embodiment of the present invention,shown connected to a medical patient, as well as to a ventilator and avacuum source;

FIG. 2 is an enlarged perspective representation of theventilator/aspirator mechanism of FIG. 1 with the control valve thereofin the unlocked, closed condition;

FIG. 3 is similar to FIG. 2 showing the aspirating vacuum control valvein cross section and the ventilating fitting in fragmentary crosssection;

FIG. 4 is an exploded side elevational view depicting the manner inwhich the sterile flexible envelope is secured at one end thereof to aforce-fit coupling associated with the ventilating fitting;

FIG. 5 is an exploded side elevation illustrating a force-fit couplingby which the flexible envelope is secured to the aspirating vacuumcontrol valve;

FIG. 6 is a cross section taken along lines 6--6 of FIG. 4, with theflexible envelope removed for clarity;

FIG. 7 is a cross section taken along lines 7--7 of FIG. 5, with theflexible envelope removed for clarity;

FIG. 8 is a further cross section of the valve of the mechanism of FIG.1 taken along lines 8--8 thereof, the valve of FIG. 8 being in itsunlocked, open condition;

FIG. 9 is a cross section similar to FIG. 8 showing the valve in itslocked, closed orientation;

FIG. 10 is a side elevational view of the ventilating fitting, withparts thereof illustrated in cross section;

FIG. 11 is a cross section taken along lines 11--11 of FIG. 10; and

FIG. 12 is a cross sectional view of the influent irrigation fittingassociated with the ventilating fitting of the mechanism of FIG. 1.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

Reference is now made to the drawings wherein like numerals are used todesignate like materials throughout. A presently preferred integratedventilator/aspirator mechanism, generally designated 20 and implementingthe provisions of the present invention, is best illustrated in FIGS.1-3. Ventilating/aspirating mechanism 20 is illustrated as beingconnected to a medical patient in FIG. 1 at a tracheostomy connector 46or an endotracheal tube and left indwelling for repeated use over aprotracted interval of time. Mechanism 20 comprises a central portioncomprising an interior sterile aspirating catheter tube 22 having ahollow interior passageway 24 of sufficient capacity to aspirate fluidsfrom the trachea and bronchi. The aspirating catheter tube 22 is formedof suitable synthetic resinous material such as medical gradetransparent polyvinyl chloride and further comprises an annular wall ofessentially uniform thickness throughout and having an outside diameterselected to pass through the throat and into the lungs of the patient.

The aspirating catheter tube 22 has sufficient strength to preventbuckling, bending and twisting of the catheter tube which occludes ortends to occlude the catheter tube. The tube 22 is surrounded in sealedrelation by a sterile sack or flexible envelope 26, formed of suitableimpervious synthetic resinous film material of medical grade, such aspolyethylene film in sleeve form. The flexible envelope 26 isselectively detachable at each end as explained herein and allows readymanual manipulation of the catheter tube 22 disposed therein ashereinafter more fully explained. The catheter tube 22 is controlledsolely by manual manipulation thereof through the envelope and is at notime subject to mechanical manipulation. Also it is preferred thatcatheter tube 22 be radiopaque to facilitate location thereof in thepatient by use of X-ray techniques.

The distal end 23 of the aspirating catheter tube 22 comprises, asillustrated, three openings, i.e. the axial opening 56 at the tip andtwo radially disposed apertures 58 and 60 in the wall of the cathetertube. See FIG. 2.

The flexible film envelope 26 comprises a first end 28 (FIG. 4), which,in the assembled condition, is secured in tight sealing thoughreleasable relation against inadvertent separation at a linear force fitcoupling, generally designated 30. Coupling 30 is releasably secured toa ventilating Tee or Cross fitting, generally designated 32. The distalend 23 of the catheter tube 22 slidably passes through both the coupling30 and the ventilating fitting 32 in sealed relation, in a manner andfor purposes hereinafter more fully explained.

The flexible envelope 26 comprises a second end 34 (FIG. 5) which is, inthe assembled condition, snugly, releasably and sealingly secured to alinear force fit coupling, generally designated 36, against inadvertentremoval. The proximal end 25 of the aspirating cathether tube 22 ispermanently anchored, adhesively or in some other suitable way, to thevalve coupling 36. Coupling 36 is associated with an aspirating vacuumcontrol valve, generally designated 40, in a manner and for purposesmore fully explained herein.

With particular reference to FIG. 1, it is to be noted that theaspirating vacuum control valve 40 is connected via an aspiratingsuction tube 42 to a vacuum source 44, e.g., a hospital suction system.FIG. 1 also illustrates the sealed attachment of the ventilating fitting32 to the trachea tube connector 46, properly surgically placed into thethroat of a patient. A ventilator 48, e.g., a hospital ventilatingsystem, is connected to the ventilating fitting 32 via hollow deliveryand exhaust tubes 50 and 52, respectively.

It is to be appreciated that a member of the hospital staff, e.g., anurse or the like, can advance the catheter tube 22 into the throat ofthe patient 54 by manually collapsing the flexible envelope 26 betweenthe thumb and fore-finger of one hand upon the cathether tube andadvancing the two, which causes the envelope to gather in an accordionfashion. The other hand is used to grip and thereby stabilize theposition of the fitting 32. When the distal end 23 of the catheter tubeis properly disposed within the patient, the nurse manually depressesthe aspirating control valve 40 to cause undesirable fluids within therespiratory system of the patient 54 to be removed under the force ofthe vacuum of source 44 along the aspirating catheter tube 22.

With particular reference to FIGS. 4 and 6, coupling 30 comprises twoforce-fit components, i.e., a stepped adapter, generally designated 70and a sleeve, generally designated 72. The adapter 70 and the sleeve 72are formed of suitable shape retaining synthetic resinous material, suchas polypropylene.

The male adapter 70 is preferably formed as one piece by suitablemolding techniques and comprises a generally annular body 74, which hasa stepped interior comprising a relatively large annular bore 76 ofuniform diameter, which merges with and terminates at an inside shoulder78. An aperture 80 is disposed in central interior wall or flange 82 andhas a relatively small diameter substantially equal to the outsidediameter of the aspirating catheter tube 22. The wall 82 comprises aradially extending, generally exposed flat surface 84. The body 74 alsocomprises a blunt end in the nature of an annular flat edge face 86,disposed in a radial plane. The body 74 further comprises a cylindricalexterior face 88, which is interrupted adjacent edge 86 by two radiallyprojecting and oppositely directed exterior cylindrical posts 90. Face88 merges with a radially directed annular face 92 at annular roundedcorner 93. Shoulder or face 92 in turn merges with a reduced diameterannular face 94 comprising part of a wall 95. Annular face 94 isinterrupted by two spaced, triangular-shaped locking rings 96. Wall 95comprises an edge 97, which merges with surface 94 at rounded annularcorner 99.

It should be clear from inspection of FIG. 6 that the aspiratingcatheter tube 22 fits snugly within the bore 80 of adapter 70.

As shown in FIG. 6, the illustrated embodiment 20 comprises a cup-shapedinsert seal, generally designated 101. Seal 101 is preferably formedfrom pliant urethane, or other suitable synthetic resinous material asone piece through conventional resin molding techniques. Seal 101 hasthe general appearance of a top hat and is sized and shaped to fitsnugly against radial wall 86, internal annular surface 76 and radialshoulder 78. More specifically, one smooth side 99 of a radiallydirected flange 103 is contiguous with radial face 86. Thus, the flange103 has a second smooth side 105, parallel to side 99, and an exposedannular surface 107. Surface 103 snugly engages the fitting 32 so that atight static seal is created between flange 103, fitting 32 and adapter70.

The flange 103 integrally merges with a thin wall central cylindricalportion 109, which has a longitudinal length essentially the same as thelongitudinal or axial length of the annular surface 76. The cylindricalportion 109 has an outside annular surface 111, the diameter of which issuch that a snug, contiguous and sealed relationship between surfaces 76and 107 exists in the assembled condition. The interior surface of thecylindrical wall 109 is serrated at 113. The serrations are pullingrings and are only a molding aid.

Cylindrical wall 109 integrally merges with an interior radiallydirected wall 115. Wall 115 is illustrated as being of uniform thicknessand as comprising a radial surface 117, which merges with serratedsurface 113, and a radial surface 119 which is sealingly contiguous withshoulder surface 78.

Wall 115 has a central aperture 121, the diameter of which is no greaterand preferably slightly less than the outside diameter of the cathetertube 22. Thus, a static and dynamic seal is created between the wall 115and the catheter tube 22 at aperture 119. Accordingly, displacement,including but not limited to reciprocation, of catheter tube 22 willcause the wall 115 to wipe the exterior surface of the catheter tubeclean and the mentioned seals prevent leakage across seal member 101 ofventilating pressure occurring within the fitting 32.

The female sleeve 72, preferably formed of polypropylene, comprises agenerally annular body wall 100 having a smooth uninterrupted exteriorannular surface 102 of uniform diameter. The annular exterior surface102 merges, fore and aft, with flat edge surfaces 104 and 106 at roundedannular corners 108 and 110, respectively. Edges 104 and 106 merge withthe interior of the sleeve 72. Interior face 112 of sleeve 72accommodates displacement of the ring 72 over annular projection 95 ofthe adapter 70 during assembly. Face 112 comprises a generally annularinterior bore having a smooth surface and a diameter slightly greaterthan the diameter of the annular face 94 of the adapter 70. The annularbore 112 is interrupted twice in the central portion thereof by V-shapedannular grooves 116, which are sized, shaped and located so as tolinearly receive the wedge or triangle-shaped projection 96 of theadapter 70 in press fit relation to assemble the coupling 30, with theflexible envelope 26 interposed between the projections 96 and thegrooves 116. Thus, annular line seals and common annular linecompressive clamp forces on both the inside and outside surfaces of theenvelope are created. As a consequence, bacteria and other contaminatesare prevented from entering the flexible envelope. Exclusive of theindwelling fitting 32, the remainder of the mechanism may be removed andreplaced by a like mechanism by simply removing the coupling 30 from itsreleasable connection to the fitting 32.

Reference is now made to FIGS. 5 and 7 for further detail concerningcoupling 36. Coupling 36 comprises a male adapter, generally designated130 and a female sleeve, generally designated 134. Each of the parts 130and 134 is formed of a suitable synthetic resinous material, preferablypolypropylene.

The adapter 130 comprises an annular wall 136. The annular wall 136comprises an interior cylindrical smooth bore 138 of uniform diameter.The wall 136 fits tightly into a bore in valve 40 as hereinafter morefully esplained and is secured in said position by a suitable adhesive.Wall 136 terminates in radial edge 139. Wall 136 also comprises anexterior cylindrical smooth surface 140. The interior bore 136terminates at step or shoulder 142. Shoulder 142 is a flat radialsurface of an inwardly directed annular wall 144. Wall 144 has a reduceddiameter central bore 146 having the same diameter as the interior boreof the catheter tube 22. Wall 144 provides a further flat shoulder 148against which one edge of the aspirating catheter tube 22 (at end 25)abuts.

The exterior cylindrical surface 140 terminates in an outwardly directedradial bridge or web 150, which is integral with the previouslydescribed inwardly directed flange or wall 144. Web 150 has disposedtherein a plurality of apertures 152, so that both sides of bridge orweb 150 are at atmospheric pressure. Radial bridge 150 merges with anannular cantilevered inside wall 154, which projects away from the valve40 coaxial of the end 25 of the aspirating catheter tube 22. Annularwall 54 comprises an interior annular smooth surface 156 having auniform diameter substantially the same as the outside diameter of thecatheter tube 22. A suitable adhesive preferably is applied to surface156 to anchor and seal the exterior surface of the end 25 of thecatheter tube 22 in the position illustrated in FIG. 7 againstinadvertent or intentional removal or loss of vacuum pressure. Note thatthe blunt edge of the catheter tube end 25 abutts the wall 144 and thatthe inside diameter of the catheter tube and the aperture 146 aresubstantially the same. The annular wall 154 comprises an exteriorsmooth annular surface 158 of uniform diameter and a blunt radial edge159.

Radial bridge 150, as shown, is also integral with a generally annularwall 160, which runs about two-thirds of the axial length of the adapter130 and concentrically surrounds all of annular wall 154 and aboutone-half the axial length of the annular wall 136. Wall 160 comprisestwo spaced interior cylindrical surfaces 162 and 164 having the sameuniform diameter. Surfaces 162 and 164 are interrupted by bridge 150.The diameter of walls 162 and 164 is greater than the respectivediameters of wall surfaces 140 and 158, whereby annular grooves 166 and168 are created. The wall 160 comprises an exterior annular generallysmooth surface 170 which is interrupted by two annular projections 172and 174, respectively, located near the end edges 175 and 177 of thewall 160.

From the foregoing, it should be readily apparent that the wall 160comprises two oppositely directed cantilevered sections, which aresupported centrally by the bridge 150 and, therefore, are substantiallyyieldable and allow linear force fit reception of the sleeve 134 withthe end 34 of the envelope 26 interposed therebetween, as hereinaftermore fully explained.

The sleeve 134 comprises an annular wall 184. Wall 184 has a smoothcylindrical exterior surface 186 of uniform diameter, which merges intoradially directed flat edges 188 and 190, at corners 192 and 194. Thewall 184 also comprises a cylindrical smooth interior surface 196.Adjacent edge 190, the smooth cylindrical interior 196 is interrupted bytwo internally directed annular radial projections 198 and 200, whichare separated by an annular groove 202.

The diameter of the cylindrical surface 196 is selected to besubstantially the same as the diameter of the projection 172 of theadapter 130, while the diameter of the projections 198 and 200 areslightly less than the diameter of the projection 174 of the adapter130. Thus, the projection 194 may be linearly force-fit into the groove202 of the sleeve 134, with the end 34 of the envelope 26 interposedbetween the projections 174, 198 and 200. As a consequence, the flexibleenvelope 26 is sealed at its inside and outside surfaces along twoclosely spaced common annular line seals and line clamps againstbacterial entry.

With specific reference to FIGS. 10 and 11, a detailed description ofthe ventilating fitting 32 will ensue. Fitting 32 is preferably formedas one piece from suitable shape-retaining synthetic resinous material,preferably polypropylene. Fitting 32 generally comprises a hollow cross(or ventilating Tee which services ventilation needs). Two of the fourports service aspiration needs. Fitting 32 comprises first, second andthird ventilating port structure 201, 203 and 205, respectively. Port201, is integrally connected to the ventilator discharge tube 52 (FIG.1), the port structure 203 is integrally connected to the ventilatorreturn tube 50 (FIG. 1), and the port structure 205 is associated with atracheostomy connector of a tracheal tube surgically placed within thepatient.

Port structure 201 comprises a cylindrical wall 206, having a smoothcylindrical exterior 208, a smooth cylindrical interior 210 and anannular projection 212 adjacent the radial edge 214 to accommodate apress fit air-tight union with one end of the ventilator tube 52.

Port structure 203 is identical to, a continuation of and integral withport structure 201, although of opposite hand, and has beencorrespondingly designated with numerals heretofore mentioned. Thecylindrical interior surface 210 constitutes a throughbore of uniformdiameter extending between the annular edge 214 of the port structure201 and the annular edge 214 of the port structure 203. Annular exteriorprojection 212 of the port structure 203 accommodates a press fitair-tight union with one end of the ventilator tube 50 (FIG. 1).

Port structure 205 is integral at interface line 216 with the wall 206forming port structures 201 and 203. Port structure 205 comprises acylindrical wall 218 of uniform thickness through defining an exteriorcylindrical smooth surface 220 and an interior cylindrical bore wallsurface 222, which opens into and thus communicates with the continuousbore 210 of the port structures 201 and 203. Accordingly, when theventilator 48 is functioning, ventilating oxygenated air is displacedalong tube 52 from ventilator 48 through the bore 210 of the portstructure 201 and thence along the bore 220 of the port structure 205into the lungs of the patient. During this phase, air flow along tube 50is prohibited by ventilator 48. After a predetermined time sufficient toallow the lungs to be adequately expanded, displacement of air fromventilator 48 through tube 52 to the lungs of the patient 54 isdiscontinued and air from within the lungs of the patient is evacuatedvia bore 222 of port structure 205 and bore 210 of port structure 203and exhaust tube 50 to the ventilator 48.

The fitting 32 also comprises port structure 230 which is generallyaxially aligned with port structure 205 and comprises two concentricallydisposed cantilevered annular walls. Port structure 230 comprises anexterior, generally cylindrical annular cantilevered wall 232, whichintegrally merges with the previously described wall 206 along arcuateinterface 234 (FIG. 10).

The outside annular wall 232 is interrupted axially and transversely byoppositely located L-shaped slots 236 into which the previouslydescribed posts 90 of the coupling 30 are tightly inserted andreleasably locked when in the assembled position, as shown in FIGS. 2and 3. The exterior cylindrical surface 238 is smooth, has a diametersubstantially the same as the diameter of the cylindrical surface 220 ofthe port structure 205 and is aligned therewith. The interiorcylindrical surface 240 of wall 232 comprises a diameter slightly lessthan the maximum transverse dimension of surface 88 of the adapter 70 sothat the adapter 70 at surface 88 fits comfortably inside of the wall232, in the assembled condition. In the assembled condition, the surface105 of flange 103 of the cup-shaped seal 101 sealingly and contiguouslyengages surface 261 of fitting 32.

The wall 232 is further interrupted by transversely directed irrigationport structure 250. Irrigation port structure 250 comprises acylindrical wall 252 integral with the wall 232 but projecting radiallyoutward therefrom a substantial distance for ready access. Irrigationport wall 252 comprises an interior smooth bore 254 of uniform diameterand an exterior cylindrical smooth surface 256 of uniform diameter.Radial bore 254 continues through the wall 232 and into fluidcommunication with the hollow interior of the fitting 32, in a fashionand for a purpose yet to be explained.

Bore 252 passes through a cylindrical interior radial rib 260 ofmaterial integrally located inside of cylindrical rib or wall 232.Interior cylindrical wall 260 merges in transverse relation withpreviously mentioned cylindrical wall or annulus 262. The wall 260comprises annular surface 261. Interior annulus 262 is generallyconcentrically disposed within cylindrical wall 232. Cylindrical wall262 comprises an interior bore 266 having a diameter substantially thesame as the outside diameter of the catheter tube 22 so that a snug sealexists when the catheter tube is located within and or displaced throughthe bore 266. Thus, ventilating pressure and oxygenated air are not lostacross surface 266. Such displacement accommodates insertion of theaspirating catheter tube 22 into and removal of the catheter tube 22from the lungs of the patient 54.

The cylindrical bore 266 terminates at the center of the transverseventilating bore 210 at flat edge 268. The bore 266 also merges withbeveled surface 270 at the exposed end of port structure 230. Beveledface 270 merges with transverse flat edge 272.

The cylindrical wall 262 extends from the center of the fitting 32coaxially with wall 232 along the port structure 230 to a locationbeyond wall 232 and comprises a generally cylindrical exterior smoothsurface 274 which merges with the exposed edge 272 and an inwardlydivergent tapered or beveled annular surface 276 which merges with theedge 268. Surfaces 276 and 274 integrally merge with the annularconnector or radial web 260.

The outside diameter of the surface 274 is such that the adapter 70 atinterior bore surface 76 slides snugly over cylindrical surface 274 asthe posts 90 are inserted into the L-shaped slots 236 and rotated toreleasably secure the coupling 30 to the fitting 32, in the assembledcondition.

The irrigation bore 254, of relatively small diameter, passes throughthe rib 260 and the wall 262 to intersect in fluid communication withthe catheter tube bore 66 such that irrigating fluid introduced throughbore 254 may be used to wash the exterior of the catheter tube asdesired, particularly during withdrawal. This is helpful in uncloggingand/or clearing the catheter tube ports 56, 58 and 60 at the distal end23 of the catheter tube 22. Introduction of solution into the lungshelps break up lung secretions. The irrigating solution is vented fromthe apparatus 20 to the ventilator 48 and to the vacuum source 44(FIG. 1) via ventilator return tube 50 and the interior of the cathetertube 22, respectively.

To faciliate introduction of irrigation solution at port 254, theprojecting annular wall 252 associated therewith is a recipient of apress fit elastomeric elbow 255. The elbow 255 is formed of highlyelastic although shape retaining material and comprises two interiorbores 257 and 259, which are of the same diameter and intersect at 90°.Elbow 255 comprises a generally cylindrical wall 261 along the short legof the elbow and a substantially cylindrical wall 263 along the longerof the two legs. The outside cylindrical surface 265 of leg wall 261 isof a slightly greater diameter than the outside diameter of thecylindrial surface 267 of the longer leg wall 263. The wall 263 isstepped at annular site 269 to a slightly greater thickness.

The elbow 255 is formed of a material, such as soft, yieldable moldedvinyl so that it may be stretched readily, but tends to return to itsoriginal shape by reason of the memory of the material from which theelbow 255 is formed. Thus, leg wall 261 may be readily expanded as it isaxially force-fit over the annular valve wall 252 to achieve theposition illustrated in FIG. 11. The force of the memory from whichelbow 255 is formed retains the elbow in said force-fit position.

By the same token, the proximal end 271 of an irrigation tube 273,having an outside diameter slightly greater than the inside diameter 259may be readily manually inserted into the longer leg wall 263 andadhesively secured at said location, if desired. (See FIG. 11.)

The end 275 of the irrigation tube 273 is secured to a hub adapter,generally designated 277 (FIG. 12). Hub adapter is preferably formed ofthe same material as elbow 255. More specifically, the distal end 275 ofthe irrigation tube 273 is inserted into the slightly smaller interiorbore 279 of the hub and retained at said location by a suitable adhesiveor the like. The bore 279 is conically enlarged at site 281 toaccommodate receipt of a syringe or a fitting associated with a sourceof irrigation fluid, when the aspirating catheter tube 22 is beingirrigated.

When irrigation is not occurring, a correspondingly shaped plug 283 istightly, although releasably inserted into the conical bore 281 toprevent entry of undesired and/or unsterile substances. The tapered plug283 is connected to an integral tether 285 molded as one piece with agenerally cylindrial hub wall 287. The tether 285 is essentiallyrectangular in its configuration. Plug 283 is also connected to acantilevered lip 289, which may be manually grasped and pulled to removethe plug 283 from the tapered port 281 when irrigation is to occur.

The generally cylindrical wall 287 comprises an exposed cylindricalexterior surface 291 which merges with a slightly larger diametercylindrical surface 293, at step or shoulder 295.

It is to be appreciated, as illustrated in FIG. 2 that during periods ofstorage and prior to connecting the aspirating/ventilating apparatus 20to the patient (as illustrated in FIG. 1), all or some of the threeventilating ports may be closed by use of a plastic force fit cap 242(FIG. 2).

Reference is now made to the illustrations of aspirating vacuum controlvalve 40 for purposes of a more detailed description thereof. Broadly,in respect to FIGS. 3, 8 and 9, valve 40 comprises a manual button orvalve actuator, generally designated 280, a main valve body, generallydesignated 282, a bottom end closure, generally designated 284, aplunger, generally designated 286 and a cup-shaped seal member,generally designated 288. All said parts, except for seal member 288,are preferably formed of one piece mold construction from a suitablerigid, shape retaining synthetic resinous material. ABS is preferredbecause it accommodates solvent bonding.

The manual actuator 280 is generally of an inverted cupshapeconfiguration. The inverted cup-shaped actuator 280 is defined by anessentially oval downwardly directed continuous flange 290 and a concaveactuator wall 292, which comprises an exposed concave oval surface 294.Concave wall 292 is of uniform thickness and comprises an interiorsurface 296 and is integrally connected to the oval flange 290 along arounded oval 90° corner 298.

The actuator 280 also comprises a centrally disposed downwardlyprojecting relatively short cylindrical post 300, used to unite theactuator 280 to the plunger 286. Post 300 is integral with the wall 292.

Also integral with the wall 292 are two elongated cylindrical posts 302and 304, each of which has a length only slightly less than the lengthof the flange 290. Cylindrical post 302 and 304 accommodate depressionof the actuator 280 when the valve 40 is unlocked and, when the valve 40is placed in its "locked" position post 302 and 304 prevent eitherintentional or inadvertent depression of the actuator 280, in a mannerhereinafter more fully explained.

The plunger 286 comprises a tubular piece having a central hollowcylindrical body 306, an annular wall 308, which defines a cylindricalbore 310. The diameter of bore 310 is substantially the same as thediameter of the post 300 of the actuator 280. Bore 310 allows air toescape fromthe interior of the sealing member 288 during assembly. Ascan be seen clearly from FIGS. 3, 8 and 9, in the assembled condition,the plunger bore 310 contiguously surrounds the cylindrical projection300 and is caused to be integral therewith preferably by utilization ofsolvent bonding. The cylindrical or annular wall 308 merges with aradially or transversely directed lower annular flange 316, whichassists in securing the plunger 286 to the sealing member 288, ashereinafter more fully explained.

The outside diameter of the annulus 308 of the plunger 286 is uniformand sized to accommodate selective reciprocation with the actuator 280from the position of FIG. 3 to the position of FIG. 8, when the valve 40is in the "unlocked" condition. The overall length of the plunger 286and the location and size of the annular wall 308 and flange 316 causethe overall length of the plunger 286 to extend beyond the centralvacuum bore of the valve 40, for purposes more fully described.

The stationary central valve body 282 of the aspirating vacuum controlvalve 40 comprises a central portion 320, which defines a centralaspirating bore 322, which has a uniform diameter throughout. Bore 322is stepped or enlarged both fore and aft. More specifically, bore 322 isenlarged at shoulder 323 to an enlarged bore 325, which opens at theexterior surface of the valve body 282. See FIG. 8, especially. Thelength and diameter of enlarged bore 325 corresponds essentially withthe available length and the outside diameter of annular wall 136 ofadapter 130. Wall 136 is fit snugly within the bore 325 until edge 139contiguously engages shoulder 323. Conventional solvent bonding, atsurface 140 of wall 136, preferably integrally unites adapter 130 withvalve body 282. See FIG. 9.

In the other direction bore 322 is twice enlarged at spaced shoulders327 and 329 to form enlarged bore segments 331 and 333, respectively.Bore segment 333 opens at the exterior surface of the valve body 282.

The bore 322 has a diameter preferably essentially the same as thediameter of the surface 138 of adapter 130.

Central valve portion 320 comprises an oppositely directed aspiratingprojection or generally annular wall 324, which has a stepped orserrated exposed exterior 326. The projection or annulus 324 isoppositely exteriorly stepped at shoulder 335 and end edge 337 to formcylindrical wall surfaces 339 and 341. Wall surfaces 339 and 341together with shoulder 335 and edge 337 taken together corresponds insize, form and shape to the surfaces 331 and 333 and shoulders 327 and329 and fit snugly therein when assembled. Conventional solvent bondingat edge 337, shoulder 335 and surfaces 339 and 341 integrally unitesprojection 324 with the valve body 282, as shown in FIGS. 3, 8 and 9.

Prior to installation of the mechanism 20, preferably the projection 324is covered by a removable cap, generally designated 330 (FIG. 8). Theillustrated removable cap 330 comprises a closed end wall 332 whichconnects to a central outwardly projecting flange 334. The wall 330terminates in an annular edge 336, sized and shaped to come to restadjacent the last enlarging step on the exposed surface 326 of theprojection 324. The wall 332 is convergently, interiorly tapered atinterior surface 338. In the illustrated configuration, the surface 338,along that portion which is contiguous with the projection 324 is shownas comprising a plurality of ribs 340, which assist in preventinginadvertent removal of the cap 330 from the position illustrated in FIG.8, thereby preserving the sterility and preventing contamination of theprojection 324 and the valve 40 during storage and prior to connectionto the patient.

At the time of installation, the cap 330 is manually removed andconnector sleeve 41 force fit over the hollow projection 324, asillustrated in FIG. 3. Connector sleeve 41 is also force fit over oneend of the aspirating vacuum tube 42.

An upwardly directed oval shaped flange 350 comprises part of valve part282 and is formed as one piece with central valve portion 320. Theinterior surface 352 of the upwardly directed flange 350 is spaced avery slight distance from the exterior surface of the actuator flange290. Thus, when in the unlocked condition, the actuator 280 may bereciprocated up and down between the positions of FIGS. 3 and 8. Theconfiguration of the flange 350 and its interior surface 352 closelymatches the oval exterior configuration of the actuator flange 290.

A pair of upwardly directed cylindrical posts 354 and 356 projectintegrally from and are formed as one piece with central valve portion320. The lengths of posts 354 and 356 are identical and, in the unlockedposition, allow clearance of the actuator posts 302 and 304 across thetops of posts 354 and 356, during actuator reciprocation. The axialspacing between flange 350 and post 354 is substantially less than theaxial spacing between the flange 350 and the post 356, so that a certaininterference is caused in the locked condition between actuator post 304and valve post 354 and between actuator post 302 and valve body post 356to lock the valve 40 against actuation.

A relatively short annular wall 358 forms part of the valve part 282 andis molded as one piece with the central valve portion 320. Annular wall358 is stepped at or has a shoulder or open groove 360 for purposes yetto be explained. The stepped annular interior of the wall 358 terminatesin a blind bore base 362, which is recessed somewhat into central valvebody 362. The base 362 of the blind bore emerges in an elongatedupwardly directed annular wall 364 of smaller although uniform insideand outside diameters. The annular wall 364 projects upwardly a distancesubstantially beyond the distance traversed by the wall 358 but to alocation beneath or lower than both the flange 350 and the posts 354 and356. The plunger 286 is disposed within but is spaced a substantialdistance from the interior bore 366 of the annular wall 364 so thatplunger reciprocation is easily accommodated.

In a downward direction, the bore 366 of the annular wall 364 mergesinto a tapered valve seat bore 368. The conical seat 368 extends fromthe top of the central valve portion 320, at site 370, to the bottom ofthe central bottom valve portion 320, at site 372.

A downwardly extending exposed or exterior flange 374 also comprises thevalve part 282 and is sized and shaped substantially identical to thepreviously mentioned flange 350, except flange 374 is downwardlydirected. Flanges 350 and 374 merge with each other at both sides of thevalve housing 282. Valve part 282 also comprises a downwardly directedinterior annular wall 376, which is disposed interior of the flange 374.The downwardly directed length of wall 376 is equal to the length of theflange 374. The interior bore 378 of the annular wall 376 is of uniformdiameter throughout and merges with the tapered valve seat surface 368at annular site 372. The bore 378 is sized and of a sufficient lengthand diameter to accommodate reciprocation of the plunger 306 along withthe surrounding seal member 288, which seal member will hereinafter bemore fully describcd.

As mentioned, the aspirating vacuum control valve 40 comprises a bottom284. Bottom 284 is preferably formed from a rigid, shape retainingsynthetic resinous material. Bottom 284 comprises a wall 380 ofsubstantially uniform thickness, defining an oval shaped edge 382, whichmatches flange 374, and a flat exposed bottom surface 384, which mergesa rounded corner at edge 382. The upper surface 386 of bottom wall 386merges with an integral upwardly directed central annulus 388, having arelatively short length. The exterior diameter of the wall 388 atsurface 390 has a diameter substantially the same as the bore 378 sothat the bottom 284 may be placed in the assembled position and thereretained by either a force-fit relationship or by use of a suitableadhesive at the interface between the bore surface 378 and the wallsurface 390.

The bottom 284 also comprises identical though opposite hand upwardlydirected arcuate wall projections 392 and 394. Arcuate projections 392are integral with wall 380, preferably formed as one piece therewithusing conventional plastic molding techniques and are sized and shapedso as to be contiguous with the interior surface of the oval flange 374.Adhesive may be placed between the projections 392 and 394 and theflange 374 to better secure the valve bottom 284 in the assembledposition.

With continued reference to FIGS. 3, 8 and 9, valve 40 also comprises aretainer/guide member, generally designated 400. Guide retainer member400 comprises an annular wall 402, having a length substantially thesame as the posts 354 and 356 and defining a cylindrical exteriorsurface 404 of uniform diameter and an interior bore 406 of uniformdiameter. The exterior surface 404 of the wall 402 is contiguous withthe interior surface of the annular wall 358 and is secured thereto, atsite 408, by use of a suitable adhesive or the like.

The wall 404 merges with a transverse disc-shaped wall 410 having thesame thickness as wall 402, but disposed at 90° thereto. Wall 410defines a shoulder or step 412 adjacent the bore 406. The transversewall 410 integrally merges with an annular wall 414, which projectsupwardly, and has a thickness substantially the same as walls 402 and410 and a length substantially less than the length of wall 402.Upwardly directed annular wall 414 comprises an exterior cylindricalsurface 416 of uniform diameter and an interior bore at cylindricalsurface 418, the diameter of which is slightly greater than the diameterof the central portion 306 of the plunger 286.

Thus, the fitting 400 and particularly the wall 414 thereof accommodatesthe previously mentioned reciprocation of plunger 286 and serves as adirectional guide to maintain plunger alignment during suchreciprocation.

The sealing member 288 is formed of a shape retaining, highly elasticsubstance such as synthetic rubber and functions not only to seal theaspirating bore 322 of the valve 40, when in the closed position, butalso as a spring by which the actuator 280 is normally biased into itselevated, closed position of FIG. 3. To achieve this objective, thesealing member 288 is stretch fitted over the plunger 286 so as to beplaced in a slight state of tension when disposed as illustrated inFIGS. 3 and 9 and in a substantially greater state of tension when inthe position of FIG. 8, the material from which the scaling member 288is fabricated having memory tending or attempting to restore the sealingmember 288 to a state of no stress.

The sealing member 288 comprises a generally annular upper end portion420 having a relatively thin wall section, the thickness thereofchanging, depending upon the amount of tension imparted thereto at anyparticular point in time. The annular wall 420 is folded upon itselfaround the annular upper edge of annular wall 364 to form annularreverse curve 422 in the sealing member, whereby the direction of thecentral wall 420 is changed from upward to downward. Beyond the reversecurve 422, the annular wall 420 fits tightly between walls 364 and 402.The end of the annular wall 420 beyond the reverse curve terminates inan enlarged annular flange 424, which is snugly received in annulargroove 362 in central valve body 320 and there retained by the union ofwall 402 to annular wall 358 at annular groove site 360. By reason ofthe sealing member 288 being secured at flange 424 within the annulargroove 362, stretch fit tension is applied to the sealing member withoutpulling the flange 424 from the groove 362.

Initially, during the assembly of the valve 40 with the bottom 284 andthe actuator 280 not yet attached, the plunger 286 is inserted upthrough the hollow bore 426 of the annular sealing member wall 420. Theplunger flange 316 is within annular slot 136 and engages contiguouslythe interior surface 428 of a bottom disc shaped wall 430. The plunger386 is also caused to extend alignedly through the bore 418 of theannular guide wall 414. The reverse curve 422 is manually created withflange 424 being contiguous with the groove 362. The retainer 400 isinstalled as described. This creates a very low level of tension in thesealing member 288. The plunger 286 is thereafter connected to theactuator projection 300, at bore 310 as heretofore explained and thebottom 284 is attached.

The annular wall 420 of sealing member 288 merges in a downwarddirection with a thicker wall portion 432, the exterior surface 434 ofwhich is conically shaped so as to correspond with the central valvebody seat 368. The interior of wall portion 432 represents essentially acontinuation of the interior bore 426, which is interrupted at the lowerend thereof by an annular enlargement 436, which accommodates theplunger flange 316 and defines a shoulder 438. Shoulder 438 aids inpreventing inadvertent upward displcement of the plunger flange 316along the bore 426 as explained earlier.

The conical exterior surface 434 terminates at a shoulder 440. Shoulder440 merges with a lower relatively short reduced diameter annular wall442. Wall 442 is integral with the bottom wall 430 of the sealingmember.

Thus, when no pressure is exerted upon the actuator 280 and the valve isin the unlocked position, the memory of the material from which thesealing member 288 is made will, pursuant to tensile stress disposedtherein, urge the actuator 280 and the plunger 286 into the elevatedposition of FIG. 3, which causes the conical sealing surface 434 tosealingly engage the central valve body seat surface 268 therebypreventing aspiration notwithstanding the vacuum force generated bysource 44 (FIG. 1).

However, because of the substantial elasticity of the sealing member288, when the valve 40 is in the unlocked position, the medicalattendant, nurse or the like, may readily aspirate fluids accumulatingwithin the trachea and/or bronchi by properly manipulating the flexibleenvelope 26 so that the catheter tube 22 therein is properly insertedinto the lungs of the patient, following which the actuator 280 ismanually depressed counter to the memory of sealing member 288 causingthe undesired fluids to be aspirated along the hollow interior 24 of thecatheter tube 22 and along the valve bore 322. The described opencondition of the unlocked valve is illustrated in FIG. 8.

On those occasions, when it is desired not to utilize the valve 40,valve 40 may be placed in the locked condition by merely slightlymanually elevating the actuator 280 between two fingers and rotating theactuator 180° so that it assumes the position illustrated in FIG. 9. Inthis position, the central valve body posts 354 and 356 are in directalignment with the actuator posts 304 and 302, respectively, asillustrated in FIG. 9, so that it is impossible to depress the actuator280 so that surface 438 is retained in its sealed relation with the seat368.

As shown in FIGS. 1 and 2, the actuator 280, at flange 290, has indicia450, comprising an eccentric mark. When the valve actuator 280 is in thelocked position, the indicia 450 will be aligned with indicia 452,comprising another mark affixed to valve housing 282. See FIG. 2. Nextto the indicia 452, the word "LOCKED" is displayed. Thus, the medicalattendant knows the valve 40 may not be actuated in the describedcondition.

When the valve actuator 280 is in the rotated and unlocked position ofFIG. 8, the indicia 450 will be aligned with indicia 454, comprisinganother mark affixed to the other side of the valve housing 282. SeeFIG. 1. Next to the indicia 454, the word "UNLOCKED" is displayed. Thus,the medical attendant knows the valve 40 is ready to be manuallyactuated as the need arises.

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The presentembodiment is therefore considered in all respects as illustrative andnot restrictive, the scope of the invention being indicated by theappended claims rather than by the foregoing description, and allchanges which come within the meaning and range of equivalency of theclaims are therefore intended to be embraced therein.

What is claimed and desired to be secured by U.S. Letters Patent is: 1.A method of manufacturing a ventilating/aspirating assembly comprisingthe steps of:assembling a manual aspirating control valve by placing aplunger in a closed end of an exteriorally tapered elastic seal memberand placing the plunger/sealing member assembly within a tapered sealingbore of a valve body having an open top and an open bottom, folding awall which comprises an open end of the sealing member upon itself inreverse curve orientation, anchoring and sealing said wall in saidreverse curve orientation in stretch fit relation thereby biasing thesealing member into a closed sealing position by forces comprising thememory of the material from which the sealing member is made; placing abottom closure and a top actuator upon the valve body followinginstallation of the plunger/sealing member assembly; linearly force-fitconnecting the distal and proximal ends of a sterility preservingflexible manually collapsible envelope respectively between aventilating/aspirating fitting and the manual aspirating control valve;stationarily connecting the proximal end of an aspirating catheter tubeto the aspirating control valve and slidably associating the distal endof the catheter tube with the ventilating/aspirating fitting.